San Diego, California 92123

  • Bacterial Infections

Purpose:

The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.


Criteria:

Inclusion Criteria: - Hospitalized male and female patients who are preterm neonates (gestational age ≥32 to <37 weeks, aged ≤28 days), term neonates (gestational age ≥37 weeks, aged ≤28 days) or young infants (aged 28 days to 3 months inclusive) who will be receiving at least 24 hours of appropriate non-investigational intravenous antiinfective treatment other than glycopeptide antibiotics for known or suspected bacterial infections. Patients with urinary tract infections due to Gram-positive organisms may be enrolled - Each patient's parent(s)/legal guardian(s) must be willing and able to provide a signed and dated written informed consent document indicating that they have been informed of all pertinent aspects of the trial - Each patient's parent(s)/legal guardian(s) must be willing and able, if patient is discharged from the hospital, to return the patient to the hospital or a designated clinic for scheduled visits, or allow a nurse to come to the patient's home for laboratory tests, PK and other out-patient procedures as required by the protocol - Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study - Sufficient intravenous access (peripheral or central) to receive Investigational Product (IP) - Patients must have an audiologic assessment within 7 days prior to the investigational product infusion consisting of ear specific hearing testing utilizing distortion product evoked otoacoustic emissions, Exclusion Criteria: - 1. Treatment with an investigational drug within 30 days preceding the dose of IP - Patients who are currently receiving intravenous vancomycin or other glycopeptide antibiotics. Dalbavancin may be administered 8 hours after the last dose of vancomycin. Vancomycin or other glycopeptide antibiotics should not be given during the 7 day period following administration of dalbavancin. If intravenous vancomycin or other glycopeptide use is unavoidable during the 7 day period following administration of dalbavancin, this should be documented as a concomitant medication - Have aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin level > 3 times upper limit of normal (neonates with elevated total bilirubin could participate if conjugated bilirubin was normal) - Albumin < half lower limit of normal - Have received a blood or blood component (eg, red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before dosing - Have any condition (eg. Septic shock, burns, cystic fibrosis, acute hemodynamic instability including those conditions requiring pressor support) that would make the patient, in the opinion of the Investigator, unsuitable for the study (eg, would place the patient at risk, compromise the quality of the data; or interfere with the absorption, distribution, metabolism or excretion of dalbavancin) - Patients known to have hypersensitivity to glycopeptides - Moderate or severe renal impairment defined as serum creatinine ≥2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis) - Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study


Study is Available At:


Original ID:

DAL-PK-02


NCT ID:

NCT03617042


Secondary ID:


Study Acronym:


Brief Title:

Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection


Official Title:

Pharmacokinetics of a Single-Dose of Dalbavancin in Preterm Neonates to Infants Ages 3 Months With Suspected or Confirmed Bacterial Infection


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

28 Days


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Allergan


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Shengfang Su
Study Director
Allergan plc
Primary Contact:Clinical Trials Registry Team
1-800-347-4500
IR-CTRegistration@allergan.com

Study Dates

Start Date:April 1, 2016
Completion Date:October 31, 2019
Completion Type:Anticipated
Primary Completion Date:October 31, 2019
Primary Completion Type:Anticipated
Verification Date:August 2018
Last Changed Date:August 21, 2018
First Received Date:August 1, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Terminal elimination half-life (T1/2).
Time Frame:Day 1, Day 2, Day 5-9 and Day 24-32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Apparent volume of distribution volume of distribution (V)
Time Frame:Day 1, Day 2, Day 5-9 and Day 24-32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Apparent total body clearance (CL) of drug from plasma
Time Frame:Day 1, Day 2, Day 5-9 and Day 24-32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Area under the plasma concentration versus time curve (AUC)
Time Frame:Day 1, Day 2, Day 5-9 and Day 24-32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Maximum plasma drug concentration (Cmax)
Time Frame:Day 1, Day 2, Day 5-9 and Day 24-32
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of patients experiencing a treatment emergent adverse event
Time Frame:Baseline (Day 1) up to Day 35
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Plasma concentration of dalbavancin
Time Frame:Day 1, Day 2, Day 5-9 and Day 24-32
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Dalbavancin
Arm Name:Cohort 1
Other Name:Dalvance®

Study Arms

Study Arm Type:Experimental
Arm Name:Cohort 3
Description:One dose of intravenous dalbavancin infusion 22.5 mg/kg in preterm neonates (defined as gestational age of 32 weeks, up to 37 weeks) aged no more than 28 days
Study Arm Type:Experimental
Arm Name:Cohort 2
Description:One dose of intravenous dalbavancin infusion 22.5 mg/kg in term neonates (defined as gestational age at or greater than 37 weeks) aged up to 28 days
Study Arm Type:Experimental
Arm Name:Cohort 1
Description:One dose of intravenous dalbavancin infusion 22.5 mg/kg in young infants aged greater than 28 days to 3 months

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Allergan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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